Treatment for primary biliary cholangitis

Abstract

The present invention provides therapeutic compound for prevention and treatment of primary biliary cholangitis, (PBC). Specifically, the present invention provides pharmaceutical composition comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, for the treatment of PBC.

1 - 14 . (canceled) 
     
     
         15 . A method of treating primary biliary cholangitis, comprising administering to a subject in need thereof an effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof, to treat the primary biliary cholangitis; wherein Formula (I) is represented by: 
       
         
           
           
               
               
           
         
       
     
     
         16 . The method of  claim 15 , wherein the compound is a pharmaceutically acceptable salt of the compound of Formula (I). 
     
     
         17 . The method of  claim 15 , wherein the compound is a metal cation salt of the compound of Formula (I). 
     
     
         18 . The method of  claim 15 , wherein the compound is saroglitazar magnesium salt. 
     
     
         19 . The method of  claim 18 , wherein the compound is administered orally to the subject. 
     
     
         20 . The method of  claim 19 , wherein the compound is administered in the form of a pharmaceutical formulation. 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . (canceled) 
     
     
         24 . The method of  claim 20 , further comprising administering to the subject at least one other therapeutic agent. 
     
     
         25 . The method of  claim 24 , wherein the therapeutic agent is ursodeoxycholic acid or a pharmaceutically acceptable salt thereof. 
     
     
         26 . The method of  claim 24 , wherein the therapeutic agent is obeticholic acid or a pharmaceutically acceptable salt thereof. 
     
     
         27 . The method of  claim 15 , wherein the subject is a human. 
     
     
         28 . (canceled) 
     
     
         29 . The method of  claim 20 , wherein the compound is saroglitazar magnesium salt, which is administered to the subject at a 4 mg dose, wherein the subject is a human. 
     
     
         30 - 39 . (canceled) 
     
     
         40 . The method of  claim 27 , wherein the compound is administered orally in an amount to provide saroglitazar or a pharmaceutically acceptable salt thereof in the range of about 1.75 to about 2.25 mg on each day the compound is administered to the subject. 
     
     
         41 . The method of  claim 27 , wherein the compound is administered orally in an amount to provide saroglitazar or a pharmaceutically acceptable salt thereof in the range of about 3.75 to about 4.25 mg on each day the compound is administered to the subject. 
     
     
         42 . The method of  claim 27 , wherein the compound is a pharmaceutically acceptable salt of saroglitazar, and said pharmaceutically acceptable salt of saroglitazar is administered orally in an amount of about 2.0 mg on each day the compound is administered to the subject. 
     
     
         43 . The method of  claim 27 , wherein the compound is a pharmaceutically acceptable salt of saroglitazar, and said pharmaceutically acceptable salt of saroglitazar is administered orally in an amount of about 4.0 mg on each day the compound is administered to the subject. 
     
     
         44 . The method of  claim 43 , wherein the compound is saroglitazar magnesium salt. 
     
     
         45 . The method of  claim 44 , wherein the compound is administered to the subject in the morning prior to the subject consuming food. 
     
     
         46 . The method of  claim 44 , wherein the compound is administered to the subject once daily. 
     
     
         47 . The method of  claim 44 , wherein the compound is administered to the subject once daily for at least 1 week. 
     
     
         48 - 55 . (canceled) 
     
     
         56 . The method of  claim 44 , wherein the compound is administered to the subject once daily for at least 16 weeks. 
     
     
         57 . The method of  claim 18 , wherein the method achieves a reduction in the amount of bile in the liver of the subject. 
     
     
         58 - 69 . (canceled) 
     
     
         70 . The method of  claim 18 , wherein the method achieves a reduction in the concentration of alkaline phosphatase in the serum of the subject. 
     
     
         71 - 82 . (canceled) 
     
     
         83 . The method of  claim 18 , wherein the method achieves a reduction in the concentration of anti-mitochondrial antibodies in the serum of the subject. 
     
     
         84 - 95 . (canceled) 
     
     
         96 . The method of  claim 18 , wherein the method achieves a reduction in the amount of inflammation in the liver of the subject. 
     
     
         97 - 108 . (canceled) 
     
     
         109 . The method of  claim 18 , wherein the method achieves a reduction in the amount of any scarring in the liver of the subject. 
     
     
         110 - 131 . (canceled) 
     
     
         132 . The method of  claim 18 , wherein the subject has an alkaline phosphatase serum concentration of at least 160 U/L. 
     
     
         133 - 136 . (canceled)